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Tiziana Life Sciences Announces Additional Clinical Improvements in the Second Patient with Non-Active Secondary Progressive Multiple Sclerosis (SPMS) After Eleven Months of Dosing with Intranasal Foralumab
The second Expanded Access patient (EA2) demonstrated additional clinical improvement in the Expanded Disability Status Scale (EDSS), a FDA recognized
About this update from Tiziana Life Sciences Ltd
[{"type":"text","content":"The second Expanded Access patient (EA2) demonstrated additional clinical improvement in the Expanded Disability Status Scale (EDSS), a FDA recognized standard clinical outcome assessment score NEW YORK, Jan. 03, 2023 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced that the second patient (“EA2”) with non-active secondary progressive multiple sclerosis (SPMS) receiving intranasal foralumab has shown additional clinical improvements since their last reported improvement in September 2022. The improvements were measured by the Expanded Disability Status Scale (EDSS), a U.S. Food and Drug Administration (FDA) - recognized standard clinical outcome assessment that is a measure of neural network functioning, rating different measures from 1 to 10 (disability increasing with higher scores). Before foralumab treatment, EA2’s non-active SPMS disability had progressed and EDSS worsened from 3.5 in 2018 to 6.0 in 2021 despite ocrelizumab therapy. Ocrelizumab was discontinued in 2021. At this point, EA2 required a cane to walk 100 meters. EA2 was subsequently enrolled in the intranasal foralumab Expanded Access program in January 2022. In September 2022, 8 months after starting treatment with nasal foralumab, EA2 was able to walk 100 meters without a cane. EDSS score improved from 6.0 to 5.5. EA2’s pyramidal score remained stable during this time. In December 2022, 11 months after starting treatment with intranasal foralumab, EA2 was able to walk 200 meters without a cane, resulting in an even greater improvement in EDSS; with EDSS falling from a score of 5.5 to 5.0. EA2’s pyramidal score continued to remain stable. Dr. Tanuja Chitnis, M.D., Professor of Neurology and the Principal investigator of the clinical study at BWH said, “The sustained improvement in EDSS score starting at 6 months and further improving after 11 months on foralumab treatment in patient EA2 is impressive and warrants further study in a Phase 2 trial. Patients with non-active SPMS normally do not improve by a sustained reduction of 1.0 on their EDSS score, so this finding is noteworthy.” Howard L. Weiner, M.D., Co-Director of the Ann Romney Center for Neurologic Diseases at BWH and Chairman of Tizian...